SPL v5
SPL
SPL Set ID bd50abcd-8a85-2923-e053-2995a90a109b
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrophosphoric Acid (0.5 g) Silicon Dioxide (14 g) .alpha.-tocopherol (0.1 g)
Inactive Ingredients
Xylitol Water Sorbitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-03-01
Description

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

Medication Information

Warnings and Precautions
  • Do not swallow and rinse mouth thoroughly after use
  • If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
  • For children under 6 years of age, use small amounts of toothpaste. And
  • use itunder the supervision of a guardian to avoid sucking or swallowing.
  • Consult a physician or dentist immediately if a child under 6 years old
  • hasswallowed large quantities.
  • Keep out of the reach of children under 6 years of age.
Indications and Usage

Brushing the teeth with a suitable amount

Dosage and Administration

For dental use only

Description

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution, Concentrated Glycerin, Carboxymethylcellulose Sodium, Hydroxyapatite, Medicinal Carbon, Chitosan, Titanium Oxide and Mica, Zeolite, Xylitol, Steviol Glycoside, Papain, Grapefruit Seed Extract, L-Menthol, Mentha Oil, Propolis Extract, Chamomile Extract, Rosemary Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract, Lavender Oil, Horsetail Extract, Sodium Cocoyl Glutamate, Lauroyl Amidopropyl Dimethyl Glycine Solution, Deionized Water

Section 51945-4

Section 55105-1

For dental health

For dental care

Section 55106-9

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

Structured Label Content

Indications and Usage (34067-9)

Brushing the teeth with a suitable amount

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)
  • Do not swallow and rinse mouth thoroughly after use
  • If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
  • For children under 6 years of age, use small amounts of toothpaste. And
  • use itunder the supervision of a guardian to avoid sucking or swallowing.
  • Consult a physician or dentist immediately if a child under 6 years old
  • hasswallowed large quantities.
  • Keep out of the reach of children under 6 years of age.
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

D-Sorbitol Solution, Concentrated Glycerin, Carboxymethylcellulose Sodium, Hydroxyapatite, Medicinal Carbon, Chitosan, Titanium Oxide and Mica, Zeolite, Xylitol, Steviol Glycoside, Papain, Grapefruit Seed Extract, L-Menthol, Mentha Oil, Propolis Extract, Chamomile Extract, Rosemary Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract, Lavender Oil, Horsetail Extract, Sodium Cocoyl Glutamate, Lauroyl Amidopropyl Dimethyl Glycine Solution, Deionized Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental health

For dental care

Section 55106-9 (55106-9)

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.897214 · Updated: 2026-03-14T23:12:02.945870